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CTRI Number  CTRI/2025/02/081366 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Yogam and Pirandai chooranam for Viyagula unmatham(Depression) 
Scientific Title of Study   Evaluation of the therapeutic effect of Siddhar Yogam and Pirandai chooranam in the management of Viyagula unmatham (Depression) in patients reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha-A Randomized, triple arm, single centric, comparative clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSiva nandiniTK 
Designation  PG Scholar 
Affiliation  National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamilnadu 
Address  Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamilnadu

Chennai
TAMIL NADU
600047
India 
Phone  9080670623  
Fax    
Email  sivanandini.oct13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrVMahalakshmi 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamilnadu

Chennai
TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrVMahalakshmi 
Designation  Professor 
Affiliation  National Institute of Siddha 
Address  Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai, Tamilnadu

Chennai
TAMIL NADU
600047
India 
Phone  9444519975  
Fax    
Email  rvmahalakshmi85@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium, Chennai-600047, Tamilnadu, India 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha, Tambaram Sanatorium, Chennai-600047 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSiva nandiniTK  National Institute of Siddha  Department of Siddhar Yoga Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Chennai
TAMIL NADU 		 9080670623

sivanandini.oct13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Internal medicine  Pirandai chooranam Dosage:2 grams twice daily after food with warm water Duration:48 days 
Comparator Agent  Nil  Nil 
Intervention  Siddhar Yogam and internal medicine  Relaxation techniques Balasanam Matsyasanam Setubandhasanam Bhujangasanam Padha hastanam Savasanam Thirumoolar Pranayamam Dhiyanam in Prithvi mudra Twice a day duration-48 days along with Pirandai chooranam Dosage:2 grams twice daily after food with warm water Duration:48 days 
Intervention  Siddhar Yogam therapy  Relaxation techniques Balasanam Matsyasanam Setubandhasanam Bhujangasanam Padha hastanam Savasanam Thirumoolar Pranayamam Dhiyanam in Prithvi mudra Twice a day duration-48 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Hamilton Depression Rating Scale (HAM D 17) score of severe depression (24 - 52) 
 
ExclusionCriteria 
Details  Use of antidepressant or psychotropic medication
H/O Psychotic disorders
H/O suicide attempts, suicidal ideation or psychosis
H/O seizure disorder
H/O hypertension and cardiac disorders
H/O spinal deformities (scoliosis, kyphosis)
Pregnant and Lactating women 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The outcome of the study will be assessed by reduction in Hamilton Depression
Rating Scale score. 		 Screening-6 months
Patient enrollment-6 months
Data analysis-1 month
Follow up-3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   09/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Depression is a common mental disorder, characterized by sadness, loss of interest or pleasure, feeling guilt or low self-esteem, disturbed sleep, appetite, lethargy and poor concentration. A depressive disorder is a syndrome that reflects a sad and irritable mood exceeding normal sadness or grief. Within ICD-11 Depressive 
disorders are specifically mentioned with the code 6A7Y. Core symptoms of depression according to ICD-11 includes depressed mood, decreased engagement in pleasurable activities, decreased enengy levels, disruptions in sleep or eating. VIyagula unmatham is mostly correlated with the symptoms of Depression in modern 
science. Viyagula unmatham is a type of unmatham which is a psychiatric disease. Pirandai chooranam is a siddha formulation used in the management of Kaba janni, Pithavatham, vali and Unmatham. In pre-clinical studies Pirandai (Cissus quadrangularis) is shown to have anti-microbial, anti-diabetic, anti-inflammatory, anti-obesity, anti-oxidant, bone turnover, cardiovascular and hepatoprotective activities. The practice of Yogam integrates the body with the mind and mind with the soul. Various techniques of yoga have been previously documented in the management of depression. So, I hope Siddhar Yogam and Pirandai chhoranam will be effective in the managemnt of Viyagula unmatham (Depression).
 
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